Kornimate/medical-research-clean huggingface dataset:
can shock indices be prognostic indicators in sepsis/septic shock?

Conditions: Shock, Septic; Hemodynamic Instability

Summary: we evaluated the ability of shock indices and hemodynamic parameters to predict 28-day icu mortality.

shock indices and hemodynamic parameters are significant determinants of mortality in adult icu patients. this study aimed to evaluate the potential of four known shock indices shock index (si), age-adjusted shock index (asi), diastolic shock index (dsi), and hemodynamic parameters including heart rate (hr), systolic arterial blood pressure (abpsys), diastolic arterial blood pressure (abpdias), and mean arterial blood pressure (abpmean) in predicting 28-day icu mortality in patients diagnosed with sepsis and septic shock.

Eligibility criteria:
inclusion criteria: 1. patients with a preliminary diagnosis of sepsis/septic shock in the intensive care unit 2. adult patients aged between 18 and 80 years exclusion criteria: 1. patients under 18 years old 2. pregnant patients 3. patients suspected of having covid-19 pneumonia 4. patients with incomplete data 5. patients for whom outcome information is unavailable due to referral to an external center 6. patients with confirmed covid-19, validated by thoracic computed tomography images and nasal swab pcr results 7. patients discharged from the intensive care unit within 24 hours
general anesthesia exposure and neurodevelopmental outcome in pediatrics

Conditions: Anesthesia; Infant Development; Anesthesia; Adverse Effect

Summary: this study investigates the impact of different levels of anesthesia exposure on children's neurocognitive development and evaluates the concurrent validity of different methods that assess neurodevelopmental outcome.

the us food and drug administration (fda) recently released an official warning regarding the potentially harmful impact of repeated and prolonged (more than three hours) general anesthesia on the child's brain. the potential impact of anesthesia highlights the importance of remediating the need for repeated and prolonged surgery with accompanying anesthesia exposure in a time of cerebral vulnerability and if possible, delay exposure to avoid potentially preventable harm. therefore, it is crucial to better understand the impact of (different durations and frequencies of) anesthesia exposure on neurodevelopment.

Eligibility criteria:
inclusion criteria: * age 12 months (± four weeks) with a history of general anesthesia exposure (patient group) or without a history of general anesthesia (healthy controls) exclusion criteria: * children with comorbid conditions affecting structure and/or function of the central nervous system (e.g. premature birth) will be excluded from participation in this study.

Keywords: anesthesiology neuropsychological test infant neurodevelopmental disorders
investigation of the prevalence of hepatopulmonary syndrome in cirrhosis patients caused by hepatitis b in western china

Conditions: Hepatopulmonary Syndrome

Summary: to investigate the prevalence of hepatopulmonary syndrome in cirrhosis patients caused by hepatitis b in western china

hepatopulmonary syndrome (hps) occurs in approximately 4%-29% of cirrhotic patients and influences mortality. china has 100 million hepatitis b virus (hbv) carriers and chronic hbv infection is well-recognized risk factor for cirrhosis.but little is known about the prevalence of hps in cirrhosis patients caused by hbv in western china. the aim of this study was to investigate the hps incidence, and the signs, symptoms, arterial blood gas, and bmp9 in the serum of the patients.

Eligibility criteria:
inclusion criteria: 1. age: 18-80 years old; 2. american association of anesthesiologists(asa) score: i-iii; 3. ability to comply with research programmes; 4. voluntary participation in the study; 5. has the history of hbv infection; 6. no primary cardiopulmonary disease (heart disease, emphysema, pneumonia, asthma, etc.) exclusion criteria: 1. severe heart, lung, kidney disease coexisted; 2. american association of anesthesiologists(asa) score≥iv; forced expiratory volume at one second (fev1) or forced vital capacity (fvc) \<70%, or fev1 / fvc \<0.70; 3. mental state could not cooperate 4. absence of written informed consent.

Keywords: hepatitis b, chronic cirrhosis hepatopulmonary syndrome
long-term effectiveness of contour augmentation in sites with early implant placement

Conditions: Jaw, Edentulous, Partially; Dental Implants, Single-tooth; Grafting Bone

Summary: in this prospective case series study, 20 patients with an implant-borne single crown following early implant placement with simultaneous contour augmentation will be followed for 10 years. clinical, radiologic, and esthetic parameters will be assessed. in addition, cone beam computed tomography (cbct) will be used at 10 years to examine the facial bone wall and compared to the 6 year data.


Eligibility criteria:
inclusion criteria: * single tooth gaps post extraction in the esthetic zone * written informed consent exclusion criteria: * heavy smoking (more than 10 cigarettes per day)
a pilot trial to determine the safety and efficacy of fluvastatin in previous partial responders to pegylated interferon and ribivirin in patients with genotype 1 hepatitis c

Conditions: Hepatitis C; Hepatitis C Virus

Summary: this study seeks to evaluate the safety and efficacy of taking fluvastatin along with peginterferon alfa in previous partial responders with genotype 1 hcv.


Eligibility criteria:
inclusion criteria: * male or female of any ethnicity age 18 - 65 years with genotype 1 hcv * previous partial responder to attempts at hcv therapy with peg/rbv (at least 1 log drop but less than 2 log drop in hcv rna at 12 weeks) * previous history or serum hcv-rna pcr quantifiable by roche amplicore hcv test * a liver biopsy within 3 years of study enrollment consistent with hcv disease. * compensated liver disease, child-pugh class ≤ 6 * negative urine pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of the study drug * all patients enrolling in the study and all partners of study participants of childbearing potential must be using two reliable forms of effective contraception during the study. exceptions may include partner/participant is surgically sterile. * willingness to comply with study procedures and provide written informed consent exclusion criteria: * ast or alt \> 10 uln * any investigational drug ≤ 12 weeks prior to the first of study drug * prior intolerance to statin medications * previous serious side effects to ifn or rbv (e.g. psychiatric side effect necessitating treatment discontinuation, severe cytopenia refractory to growth factors, intolerance to ifn/rbv requiring treatment discontinuation) * any systemic antiviral therapy ≤ 24 weeks prior to the first dose of study drug or expectation that such treatment will be needed at any time during the study. exception: patients who have taken or are expected to require such treatment for herpetic lesions * positive test at screening for anti-hav igm ab, hbsag, anti-hbc-igm ab ,or anti-hiv ab * serum concentrations of cerulplamin or alph-1-antitrypsin consistent with an increased risk of metabolic liver disease * history or other evidence of a medical condition associated with chronic liver disease (e.g. hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposure, nonalcoholic steatohepatitis) * women who are pregnant or breastfeeding and male partners of woman who are pregnant or breastfeeding

Keywords: genotype 1 hepatitis c hepatitis c hcv liver
phase 1b long-term extension trial of ray121 in immunological diseases (rainbow-lte trial)

Conditions: Antiphospholipid Syndrome (APS); Bullous Pemphigoid (BP); Behçet's Syndrome (BS); Dermatomyositis (DM); Immune-mediated Necrotizing Myopathy (IMNM); Immune Thrombocytopenia (ITP)

Summary: this is a long-term extension trial of ray121 in patients with immunological diseases such as antiphospholipid syndrome (aps), bullous pemphigoid (bp), behçet's syndrome (bs), dermatomyositis (dm), immune-mediated necrotizing myopathy (imnm) and immune thrombocytopenia (itp).


Eligibility criteria:
inclusion criteria: 1. signed informed consent form 2. have completed 4 doses of ray121 administrations in ray902ct trial and shown clinical responses 3. ability to comply with the study protocol, in the investigator's judgment 4. for women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive methods during the treatment period and 20 weeks (140 days) after the last dose of ray121 5. for men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm exclusion criteria: 1. history of anaphylaxis or hypersensitivity to a biologic agent 2. known active infection with encapsuled bacteria 3. history of neisseria meningitidis infection 4. planned surgery 5. pregnant or breastfeeding, or intending to become pregnant 6. clinically significant electrocardiogram abnormalities 7. illicit drug or alcohol abuse 8. known or suspected immune deficiency 9. treatment with investigational therapy other than ray121 10. vaccination with a live vaccine within 4 weeks
enoxaparin versus aspirin in patients with cancer and stroke

Conditions: Cancer Patients First-ever Acute Ischemic Stroke

Summary: patients with cancer who develop stroke are at high risk for future strokes or other clotting events. these patients are routinely treated with medicines that thin their blood, including enoxaparin or aspirin. however, it is unclear which medicine is best and whether these medicines can be adequately studied in a clinical trial. the purpose of this phase i/ii study is to determine if a clinical trial of different blood thinners in patients with cancer and stroke is possible. in addition, the study aims to compare the effects, good and/or bad, of enoxaparin with those of aspirin on patients with cancer and recent stroke.


Eligibility criteria:
any adult patient with active systemic cancer diagnosed with acute ischemic stroke at the main mskcc campus or at any of mskcc's new york city outpatient center wcmc, nyph/cumc within the prior four weeks would be eligible. inclusion criteria: * 18 to 85 years of age. * active cancer, defined as a pathologic diagnosis of or treatment for any cancer, other than basal-cell or squamous-cell carcinoma of the skin, within the past six months; or patients with known recurrent or metastatic disease within the past six months. * a pathology report issued at the enrolling site confirming the diagnosis of cancer is required for enrollment. * acute ischemic stroke within the prior four weeks, defined as a new neurologic deficit(s) with mri evidence of acute ischemia in a referable location, and no clinical or radiologic indication of a non-cerebrovascular mimic, such as a brain metastasis, as the etiology of the deficit(s). exclusion criteria: * inability to get brain mri * known malignant primary brain tumor. * diagnosis of intracranial hemorrhage within the past 3 months, including intratumoral hemorrhage into brain metastases from a systemic cancer. * active or serious bleeding within two weeks of enrollment. * patient condition associated with a high risk of bleeding such as recent surgery or peptic ulcer disease. * clear indication for anticoagulation (e.g., atrial fibrillation) anticipated during the study period. * clear indication for antiplatelet agents (e.g., cardiac stents); a patient receiving aspirin for primary prevention prior to index stroke may be enrolled as long as study investigators believe it would be safe for the patient to stop aspirin if the patient was randomized to the enoxaparin arm. * active bleeding diathesis. * platelet count of ≤ 70,000/mm3, an international normalized ratio (inr) \> 1.6, or a partial thromboplastin time (ptt) \> 40 seconds. * known allergy to heparin or aspirin or a history of heparin induced thrombocytopenia. * serum creatinine \> 2 mg/dl. * ast or alt \> 200 u/l. * hemoglobin \< 8 gm/dl * symptomatic carotid stenosis. * active pregnancy. * life expectancy \< 1 month or current hospice care * unavailability for follow-up.

Keywords: enoxaparin aspirin stroke 12-264
phase i/ii dose ranging chronseal® study in venous leg ulcers

Conditions: Chronic Venous Leg Ulcers

Summary: the purpose of this study is to evaluate if the investigational medicinal product chronseal intended for future treatment of chronic venous leg ulcers is safe and tolerated and if it has an ulcer size reduction effect when administered to individuals suffering from venous leg ulcers.


Eligibility criteria:
inclusion criteria (run-in period): 1. caucasian male or clinically sterile female subjects 2. 40 years or older. 3. ankle brachial index of at least 0.6. 4. written informed consent obtained. 5. subject legally competent and able to communicate effectively. 6. subject likely to co-operate. 7. uncomplicated venous ulcer as by clinical diagnosis. 8. full skin ulcer. 9. localisation above the foot and below the knee (wrist and malleoli included) 10. duration of at least 3 months. 11. area 3-20 cm2. exclusion criteria (run-in period) 1. visible signs of infection, black necrosis or discharge in the target ulcer. 2. more than \~20% slough after debridement. 3. ulcer that by location or extension will either be difficult to follow or to treat according to the protocol. 4. other known etiology of the target ulcer. 5. subject having to the discretion of the investigator clinically significant findings on physical examination or vital signs. 6. concomitant systemic or topical treatment within 14 days prior to start of study medication with antibiotics or antiseptics for treatment of ulcer infection in target ulcer. 7. concomitant systemic treatment within 14 days prior to start of study medication with immunosuppressives 8. concomitant topical treatment within 14 days prior to start of study medication with any of the following: * nsaids, aspirin * growth factors, or other biologically active agents * products containing chlorhexidine, potassium permanganate, iodine or silver 9. diabetes mellitus requiring pharmaceutical treatment. 10. co-morbidity with a life expectancy less than 6 months. 11. co-morbidity expected to lower compliance. 12. diagnosed kidney disease 13. individuals sensitive to any of the study medication components. 14. subject having received an investigational drug product, or been enrolled in other investigational drug protocols within a period of 30 days prior to receiving the first dose of the study medication. 15. known abuse of alcohol, drugs or pharmaceuticals. 16. diagnosis of squamous epithelia carcinoma 17. diagnoses of a serious psychiatric illness which may influence study participation. inclusion criteria (randomization) 1. subject likely to co-operate. 2. ulcer area reduction less than 50% during run-in period. 3. ulcer area 3-20 cm2. exclusion criteria (randomization) 1.\& 2. = run-in period criteria 1. \& 2. 3. subject having to the discretion of the investigator clinically significant findings on vital signs or laboratory values. 4.-10. = run-in period criteria 6., 7., 8., 11., 12., 13., \& 14
efficacy and safety of tulobuterol patch combined with tiotropium bromide for relieving dyspnea symptom of chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease

Summary: phrase: iv indication: dyspnea symptom of chronic obstructive pulmonary disease (copd) objective: to evaluate efficacy and safety of tulobuterol patch combined with tiotropium bromide for relieving dyspnea symptom of copd design: a multi-centre randomized parallel blank control study case number: test group 80, control group 80, totally 160 site number:7 study period: 2010.9 - 2011.8


Eligibility criteria:
inclusion criteria: * people aging from 40 to 80 with self ability of judgment * out-patients diagnosed as stable copd according to "diagnosing and treatment guideline of copd (2007 edition)" by respiratory department of chinese medical association * pft value at screen phase meet the standard as follows: fev1/fvc \< 70% and fev1% among 30%-80% 15 mins after inhalation of 400ug ventolin (i.e., moderate and severe copd patients ). * people who can use tiotropium bromide powder inhalation device * people who join the study voluntarily and sign icf (informed consent form) exclusion criteria: * people who have other acute or chronic respiratory diseases which may cause impairment of pulmonary function such as asthma * aecopd （acute exacerbation of copd） * people who got respiratory failure 1 month before the study * people who received oral corticoid treatment 1 month before the study * people who undergo oxygen therapy at home because of respiratory failure * people who are allergic to β2 receptor agonist such as tulobuterol * patients with skin diseases such as atopic dermatitis, who are not appropriate to use transdermal patch * patients of hyperthyroidism, hypertension, heart disease and severe arrhythmia, diabetes mellitus, who are not appropriate to useβ2 receptor agonist * patients who have undergone pulmonary lobectomy or have tumor * active tuberculosis patients * people who got acute respiratory tract infection in a month or during screening phase * allergic rhinitis patients * glaucoma patients * people who have diseases which may cause dysuria such as prostatic hypertrophy or bladder neck occlusion * gestation, lactation and child-bearing age women who don't agree to take contraceptive measures during the study * people with abnormal live or kidney function, people with nervous system diseases, malignant tumor, neutropenia or other progressive basic diseases. * people who are mental retardation, mentally ill, deaf-mute or uncooperative, who cannot correctly describe their disease or do corresponding respiratory questionnaire. * people who are allergic to atropine and its derivatives (including tiotropium bromide and ipratropium bromide), lactose or any inhalant components. * people who have taken part in other medical clinical trial * other conditions that investigators think not appropriate for the study

Keywords: copd
covid-19 vaccine education at the point of testing to increase vaccine uptake in vulnerable communities in se louisiana

Conditions: Covid19; Vaccine Refusal; Vaccine Hesitancy

Summary: this project is a 2-year study to investigate vaccine hesitancy and vaccine completion among vulnerable communities in the southeastern louisiana region. this study will be used to track covid-19 vaccine completion among patients who seek testing, either as in-person or purchasing at home covid testing, from pharmacies, urgent cares and clinics using a rapid vaccine education model delivered at the point of care.

this project is a 2-year study to investigate vaccine hesitancy and vaccine completion among vulnerable communities in the southeastern louisiana region. this study will be used to track covid-19 vaccine completion among patients who seek testing, either as in-person or purchasing at home covid testing, from pharmacies, urgent cares and clinics. the proposal will introduce a rapid vaccination education model to be delivered at the point of covid-19 testing by pharmacy students, pharmacy technicians, nurse's aides and other health care personnel and includes monitoring for covid-19 vaccine completion among enrolled patients. investigators anticipate an increase in covid-19 vaccine completion rates for those who participate in the rapid vaccination education model.

Eligibility criteria:
inclusion criteria: * unvaccinated adult participants, 18-99 years of age, able to provide informed consent, and to communicate in english, spanish or arabic. also, individuals with incomplete vaccination (primary series or covid-19 booster). exclusion criteria: * persons fully vaccinated for covid-19 (including primary series and boosters), persons with any documented allergies to components of the covid-19 vaccines, or contraindications to receiving a covid-19 vaccine.

Keywords: vaccine completion covid19 testing covid19 education point of care testing healthcare personnel education healthcare disparities
effects of daily interruption of sedatives in critically ill children

Conditions: Critical Illness

Summary: critically ill children are often sedated in order to relieve them from anxiety and discomfort, and to facilitate their care. there is little information on the effects of prolonged and continuous use of sedatives and analgesic agents in critically ill children. in adult intensive care unit (icu) patients, daily interruption of sedative infusions accelerates recovery resulting in a reduction in the average duration of mechanical ventilation of 2.4 days as well as a reduction in average icu length of stay of 3.5 days. these results were achieved without an increased rate of adverse events potentially linked to less sedation and associated with a reduction of common complications of critical illness and without negative psychological effects. it is unknown whether these results can be extrapolated to critically ill children. moreover, the possible risk of complications associated with less sedation, such as accidental self-extubation, is probably higher in children. also, the need for intermittent bolus administrations in children treated with intermittent sedation could nullify the reduction in the use of sedatives. it is unknown if daily interruption of sedatives is feasible in critically ill children. the researchers studied the effects of daily interruption of sedatives in critically ill children on the total amount of sedatives used and risks of complications.


Eligibility criteria:
inclusion criteria: * intubated and mechanically ventilated for \> 24 hours * expect further mechanical ventilation for \> 48 hours * receiving midazolam and morphine for sedation * written informed consent given by parents exclusion criteria: * inclusion in another trial * transfer from an outside institution where sedatives had been administered * neuromuscular blockers * metabolic disease * neuromuscular disease * encephalopathy * epilepsy * pulmonary hypertension * neurotrauma * raised intracranial pressure * life expectancy less than a month/infaust prognosis

Keywords: interruption critically ill sedation pediatrics critically ill, ventilated children
preventing postpartum depression in prenatal care

Conditions: Post-partum Depression

Summary: this is randomized control trial of a brief intervention called bellevue rose (reach out stay strong essentials). bellevue rose is a manualized and highly structured interpersonal intervention that provides women with psycho-education about maternal depression and strategies for strengthening social support and connectedness. investigators use motivational interviewing strategies to improve treatment compliance and resource acquisition


Eligibility criteria:
inclusion criteria: * english speaking * women who score between 5-19 on the phq-9 and \>23 on the anrq exclusion criteria: * women who score \ 19 on the phq-9 * women who are currently suicidal, active substance users, currently experiencing domestic violence, or have a current or past history of bipolar or psychotic disorder diagnosis. * women who are currently in treatment for psychotherapy. * unable to speak and/or understand english proficiently * unable to provide informed consent

Keywords: psycho-education maternal depression reach out stay strong essentials